Medical Devices

IDE Institutional Review Boards (IRB)

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights, safety and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights, safety and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents). The IRB must monitor and review an investigation throughout the clinical study.

If an IRB determines that an investigation involves a significant risk device, it must notify the investigator and, if appropriate, the sponsor. The sponsor may not begin the investigation until approved by FDA.

FDA requires IRB registration. This requirement can be found under 21 CFR 56.106. The institutions where the study is to be conducted should be contacted to determine if they have their own IRB. If the study is conducted at a site that does not have its own IRB, the investigators should be queried to see if they are affiliated with an institution with an IRB that would be willing to act as the IRB for that site in the study. There are also independent/contract IRBs that can be contracted with to act as the IRB for a site. (Please note: FDA does not approve or endorse any IRBs.) Additionally, an IRB can be established in accordance with 21 CFR 56.

An IRB must comply with all applicable requirements of the IRB regulation (Part 56) and the IDE regulations (Part 812) in reviewing and approving device investigations involving human testing. FDA does periodic inspections of the IRB’s records and procedures to determine compliance with the regulations.